1. Risk Management Case Study: The RADARS® System
Dr. Kenneth Hintze, Director, Global Safety & Pharmacovigilance

2. Kendle’s Role Ensure regulatory compliance Identify adverse events
Process adverse events
Report serious adverse events to FDA and Purdue Affiliates
Keep Purdue informed of metrics
Work within Purdue’s adverse event database

3. RADARS® System Poison Control Center (PCC) Program Key Informants
34 PCCs participating with 6 to be added
Receipt of records managed through the Rocky Mountain Poison Control Center
Receive ~500 records weekly
Records processed to date: 47,927
Key Informants
~ 170 records received quarterly
Records processed to date: 1604

4. Work Process PCC’s send records as PDFs Records for trade name
drugs sent to
manufacturers
Non-Purdue
drugs
Records printed
dated, sorted
Non events
Adverse events
processed, coded
narrative created,
medical review
MedWatch
to FDA
Non-serious
CIOMS
to affiliates
Serious

5. Records Processed by Drug

6. Key Elements Training Learning Purdue products
Computer system conventions
Establishing VPN connection
Establishing system for receipt of records from the Rocky Mountain Poison Control Center
Communication

7. Challenges Deciphering records Inability to conduct follow-up
Variation in record cases
Understanding Emergency Room or Intensive Care Unit standards, protocols, lab values and test norms
NDA annual & Periodic Safety Update reports

8. The RADARS® System